Catalog Number

66-MP-EH

Brand Name

WayPoint™ Entry Offset Mounting Hub

Version/Model Number

66-MP-EH-00604

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2018

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092192,K092192

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

2c693999-e02e-4c0e-b7f0-00e3a0c9d6e0

Public Version Date

December 19, 2018

Public Version Number

3

DI Record Publish Date

April 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-